FDA expands Opdivo-Yervoy approval for lung cancer
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The FDA expanded the approval of nivolumab plus ipilimumab for treatment of lung cancer, according to the agents’ manufacturer.
The new indication applies to use of the two agents combined with limited chemotherapy as first-line treatment of adults with metastatic or recurrent non-small cell lung cancer who do not have EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Nivolumab (Opdivo, Bristol-Myers Squibb) is an anti-PD-1 antibody. Ipilimumab (Yervoy, Bristol-Myers Squibb) is an anti-CTLA-4 antibody.
The regimen covered by this approval is nivolumab dosed at 360 mg plus IV ipilimumab dosed at 1 mg/kg given with two cycles of platinum-doublet chemotherapy. It is indicated for patients with squamous or nonsquamous disease, regardless of PD-L1 expression.
The FDA based the approval on results of the randomized phase 3 CheckMate -9LA trial, which included 719 patients with metastatic or recurrent NSCLC.
Researchers assigned 361 patients to first-line treatment with nivolumab plus ipilimumab combined with two cycles of platinum-doublet chemotherapy. The other 358 patients received four cycles of platinum-doublet chemotherapy, followed by optional pemetrexed maintenance therapy if eligible. Treatment continued until disease progression or toxicity.
OS served as the primary efficacy outcome. Other efficacy outcome measures included PFS, overall response rate and duration of response.
Results of a prespecified interim analysis performed after minimum follow-up of 8.1 months showed patients assigned nivolumab plus ipilimumab achieved longer OS (median, 14.1 months vs. 10.7 months; HR = 0.69; 96.71% CI, 0.55-0.87). A follow-up analysis at 12.7 months showed even greater OS benefit with the combination (median, 15.6 months vs. 10.9 months; HR = 0.66; 95% CI, 0.55-0.8).
More patients assigned the nivolumab-ipilimumab regimen remained alive at 1 year (63% vs. 47%). ORR per blinded independent central review also was higher in the combination group (38% vs. 25%).
“We have come a long way in understanding the role of dual immunotherapy-based approaches in cancer and the potential impact on patients’ long-term outcomes,” study investigator David P. Carbone, MD, PhD, director of the James Thoracic Oncology Center at The Ohio State University, said in a Bristol-Myers Squibb-issued press release. “The positive findings from CheckMate -9LA demonstrate the benefit of combining dual immunotherapy with limited chemotherapy for [patients with NSCLC] regardless of PD-L1 status.”
Nearly one-quarter (24%) of patients in the CheckMate -9LA trial who received the combination experienced discontinued treatment due to adverse reactions, and 56% had at least one treatment withheld due to adverse events.
The most common adverse reactions included fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%) and pruritus (21%). The most frequent serious adverse events included pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis and respiratory failure.
Seven patients (2%) experienced fatal adverse events. These included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia and massive hemoptysis in the setting of thrombocytopenia.
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